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U.S. Department of Health and Human Services

Class 2 Device Recall 2 over 2 elevating monitor suspension system

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  Class 2 Device Recall 2 over 2 elevating monitor suspension system see related information
Date Initiated by Firm March 23, 2017
Date Posted June 19, 2017
Recall Status1 Terminated 3 on December 11, 2019
Recall Number Z-2621-2017
Recall Event ID 77458
Product Classification Monitor, patient position, light-beam - Product Code IWE
Product Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory

Device accessory that elevates monitor for healthcare professionals.
Code Information SKF Telescopic Pillar P/N ending in -003
Recalling Firm/
Manufacturer		 Omega Medical Imaging, Inc.
675 Hickman Cir
Sanford FL 32771-6931
For Additional Information Contact John Newman
407-323-9400 Ext. 203
Manufacturer Reason
for Recall		 Elevating Monitor Suspension column dropping and will not rise back up.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The firm, OMEGA MEDICAL IMAGING, sent a "Field Safety Advisory Notice" dated 3/23/2017 to consignees. The notice described the product, problem and actions to be taken. The consignees were instructed to immediately examine the product and confirm correct product information; immediately discontinue use; move monitor suspension away from staff personnel and patients; and advising consignees to take photos of affected product and the P/N label. Photos of product labels are to be sent to jnewman@omegamedicalimaging.com at Omega. Product is to be corrected. If there are any questions or concerns, please feel free to contact us at 407-323-9400 Ext 203 or email: omegamedicalimaging.com or jnewman@omegamedicalimaging.com.
Quantity in Commerce 6 units
Distribution Worldwide Distribution -US Distribution to states of: IN, OH, PA, and MT; and country of: Pakistan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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